Apparatus and method for reversibly closing a natural or implanted body passage

ABSTRACT

An apparatus and method for reversibly closing a natural or implanted body passage which utilize an implantable fluid reservoir and a distensible member that is adapted to be connected to the natural or implanted body passage. An implantable pump is connected to the fluid reservoir and the distensible member for pumping fluid from the reservoir to the distensible member to distend the distensible member and cause the reversible closing of the natural or implanted body passage.

United States Patent 1 Summers 11] 3,750,119% [451 Aug. 7, 11973APPARATUS AND METHOD FOR REVERSIBLY CLOSING A NATURAL OR IMPLANTED BODYPASSAGE [75] Inventor: George D. Summers, Bethesda, Md.

[73] Assignee: Fairchild Industries, Inc.,

Germantown, Md.

22 Filed: Mar. 16, i971 211 App1.No.: 124,718

[52] U.S. Cl. 3/1, 128/1 R, 128/346, 128/349 R, 128/350 R, 128/DIG. 25

[51] Int. Cl. A61f l/00, A6lf1/24, A6lb 17/00 [58] Fieid of Search 3/1;128/346, 350 V, 128/1 R, DIG. 25, DIG. 21, 348-350, 327

[56] References Cited UNITED STATES PATENTS 3,419,008 12/1968 Plishner128/346 2,455,859 12/1948 Foley 128/346 3,538,917 11/1970 Selker 128/346X 2,494,393 l/l950 Lamson 128/1 R 3,527,220 9/1970 Summers 3/1 X FOREIGNPATENTS OR APPLICATIONS 1,174,814 12/1969 Great Britain 128/D1G. 25

OTHER PUBLICATIONS A New Miniature Pump For the Treatment ofHydrocephalus" by G. D. Summers et a1., Journal of the Assoc. for theAdvancement of Medical Instrumentation, V01. 2, No. 3, May/June 1967,pp. 9-15.

Netherlands 3/] France 3/1 Primary Examiner-Richard A. Gaudet AssistantExaminer-Ronald L. Frinks Attorney-Michaei W. York [57] ABSTRACT Anapparatus and method for reversibly closing a naturai or implanted bodypassage which utilize an implantable fluid reservoir and a distensiblemember that is adapted to be connected to the natural or implanted bodypassage. An implantable pump is connected to the fluid reservoir and thedistensible member for pumping fluid from the reservoir to thedistensible member to distend the distensible member and cause thereversible closing of thenatural or implanted body I passage.

9 Cinims, 8 Drawing Figures PKTE'N'TEDMIG" 1 m5 750, 194

sum 1 or 2 INVENTOR GEORGE D. SUMMERS ATTORNEY PATENTEDMJS 1 ms3.750.194

sum 2 0r 2 INVENTOR GEORGE D. SUMMERS FIG. 7 BY ATTORNEY APPARATUS ANDMETHOD FOR REVERSIBLY CLOSING A NATURAL OR IMPLANTED BODY PASSAGEBACKGROUND OF THE INVENTION A great many persons suffer fromnon-functioning or malfunctioning sphincters which are circular bands ofvoluntarily or involuntarily controlled muscles which encircle anorifice of the body or body canal or one of the bodyls hollow organs.This condition can be brought on by congenital malformations, trauma tothe sphincter nerves or muscles, disease of the sphincter nerves ormuscles, or other body pathologies.

Among the most troublesome and embarrasing conditions brought about bythe lack of proper control of one or more sphincters are malfunctions ofthe urethral and anal canals. The urethral sphincter controls thecontainment of urine in the bladder until the sphincter is relaxed topermit passage of urine from the bladder and the anal sphincter controlsthe containment of fecal matter in rectum until it is relaxed to permitpassage of fecal matter from the rectum. As a result of the malfunctionof the anal or urethral sphincters, uncontrolled drainage of fecalmatter and urine from the body can occur and this is embarassing to theindividual and can restrict his activities. In addition tomalfunctioning sphincters, other individuals have had colostomies and asa result have an artificial opening for the bowels that lacks anysphincters to control the opening.

A number of attempts have been made in the past to provide substitutesfor such malfunctioning sphincters or to provide some means forcontrolling artificial openings that have no natural sphincters. Varioustypes of inflatable devices such as the artificial darn disclosed in US.Pat. No. 2,494,393 have been proposed that are insertable into a naturalor artificial body canal from outside the body and are inflatable toobstruct the artificial or natural opening so that seepage does notoccur from the opening. However, such devices are uncomfortable to wearand are not entirely successful. Various surgical procedures have beenattempted to repair damaged and diseased sphincters and electriccurrents have also been used in attempts to cause the spincters toeither contract or relax. Again such procedures have not been entirelysuccessful and if the electric currents are provided through the use ofexternal electrical devices that are inserted into body orifices thismay not be cosmetically or psychologically desirable.

The implantable apparatus and method of the present invention overcomesthe disadvantages of such prior devices and techniques and allows a bodypassage or canal to be reversibly closed in an efficient manner withoutundue discomfort to the individual whose body passage is beingcontrolled.

SUMMARY OF THE INVENTION This invention relates to apparatus and methodsfor reversibly closing a natural or implanted body passage and moreparticularly to apparatus and methods that utilize a distensible member.

lt is an object of the present invention to provide an implantableapparatus that can efficiently reversibly close an implanted or naturalbody passage.

It is an object of the present invention to provide an implantableapparatus that is readily operable by the individual in whom it isimplanted to reversibly close an implanted or natural body passage.

It is an object of the present invention to provide an implantableapparatus that is cosmetically and psychologically acceptable to theperson in whom it is implanted.

It is also an object of the present invention to provide an implantableapparatus that can reversibly close a natural or implanted urinarypassage.

It is also an object of the present invention to provide an implantableappartus that can reversibly close a portion of a naturalor implantedalimentary canal.

It is also an object of the present invention to provide a method forreversibly closing a natural or implanted body passage that utilizesimplantable distensible means.

It is also an object of the present invention to provide a method forreversibly closing a natural or implanted urinary passage.

It is also an object of the present invention to provide a method forreversibly closing a natural or implanted alimentary passage.

- The present invention provides an implantable apparatus for reversiblyclosing a natural or an implanted body passage that includes animplantable fluid reservoir and implantable distensible means adapted tobe operatively connected to the natural or implanted artificial bodypassage for reversibly closing the passage. The implantable apparatusalso includes implantable pumping means operatively connected to saidfluid reservoir and the distensible means for pumping fluid from thefluid reservoir to the distensible means to cause distension of thedistensible means to reversibly close the passage and to pump fluid fromthe distensible means to open the passage. The present invention alsoprovides a method for reversibly closing a natural or arificial bodypassage that includes the steps of implanting an implantable fluidreservoir, implanting implantable pumping means operatively connected tothe implantable fluid reservoir, and implanting distensible meansoperatively connected to the pumping means in the body and during suchimplantation operatively connecting the distensible means to the naturalor implanted body passage. The method further includes the steps ofactivating the pumping means to pump fluid from the implantable fluidreservoir to the distensible means to cause distension of thedistensible means to reversibly close the natural or implanted bodypassage when it is desired to close the natural or implanted bodypassage and activating the pumping means to pump fluid from thedistensible means to the implantable fluid reservoir to cause deflationof the distensible means to open the natural or implanted body passagewhen it is desired to open the natural or implanted body passage.

BRIEF DESCRIPTION OF THE DRAWINGS The invention will be hereinafter morefully described with reference to the accompanying drawings in which:

FIG. H is a diagramtic view of the implantable apparatus of the presentinvention implanted within the body of a human;

FIG. 2 is a perspective view of the implantable apparatus of the presentinvention and means locatable outside the body for operating theimplantable apparatus;

FIG. 3 is a sectional view taken on the line 3-3 of FIG. 2;

FIG. 4 is a plan view of a portion of the structure illustrated in FIG.2;

FIG. 5 is a diagramatic view of an alternative embodiment of theimplantable apparatus of the present invention implanted within the bodyof a human;

FIG. 6 is an enlarged view of a portion of the body and the implantedapparatus illustrated in FIG. 5;

FIG. 7 is an enlarged plan view of a portion of the structureillustrated in FIG. 6; and

FIG. 8 is a sectional view of a portion of the human body illustratingthe use of the present invention in controlling the alimentary canal.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring first toFIG. 1 the implantable portion of the apparatus of the present inventionfor reversibly closing a natural or an implantable artificial bodypassage, generally designated by the number 10, is illustrated as beingimplanted within the body of a human being 11. The implantable apparatus10 comprises an implantable fluid reservoir 12 and implantabledistensible means generally designated by the number 13 illustrated asbeing adapted to be operatively connected to a natural or implanted bodypassage which as illustrated is a natural or artificial urethra 14 whichis connected to the bladder 15 which is in turn connected to the kidneys16. The implantable apparatus 10 also comprises implantable pumpingmeans generally designated by the number 17 that is operativelyconnected to the fluid reservoir 12 and the distensible means 13 by animplantable fluid conduit 18. Pump activating means 19, locatableoutside the body 11, for activating the pumping means 17 is illustratedas being in position to operate the pump means 17.

The details of the implantable apparatus 10 and the pump activatingmeans 19 are illustrated in FIGS. 2 through 4. The implantable fluidreservoir 12 comprises a distensible bladder 20 that is adapted toexpand or contract due to the action of a fluid 21 that is containedwithin the bladder. The bladder 20 comprises an outer layer 22 that iscompatible with body tissue and an inner layer 23 that is impervious toand compatible with the fluid 21. The bladder 20 has tabs 24 located atintervals around its outer edge that have holes 25 that permit a surgeonto anchor the tabs within the body 11 and thus secure the bladder withinthe body. Located on the front side of the bladder 20 that is adapted tobe located close to the skin of the body 11 is a self sealing membrane26 that is adapted to be punctured by a hypodermic needle (not shown)that can be inserted into the body and the bladder to either add fluid21 to the bladder or withdraw fluid from the bladder. Located around theself sealing membrane 26 is a metallic ring 27 that protrudes above thesurface of the bladder and permits the person who is administering tothe needs of the patient to readily locate the ring by touching the body11 and thus permit the person to readily locate the self sealingmembrane. A polycarbonate plate 28 is located beneath the self sealingmembrane 26 and is attached to the inside opposite wall of the bladder20 to prevent the inadvertent puncturing of the bladder by thehypodermic needle that is inserted into the bladder through the selfsealing membrane.

The pumping means 17 comprises a rotary pump that has a generally discshaped hollow casing 29 that has an outer layer or coating 30 that iscompatible with body tissue. Located within the pump casing 29 is agenerally triangular shaped pump rotor 31 and a disc shaped magnet 32that is securely attached to the upper side of the rotor. Both the rotor31 and the magnet 32 are rotatably mounted within the casing 29 on ashaft 33 that has its lower end secured to inside lower surface of thepump casing. The casing 29 has respective inlet and outlet holes 34 and35 located in its side walls approximately opposite each other that areadapted to receive respective inlet and outlet sections 36 and 37 of theimplantable fluid conduit 18. The outermost end of the inlet section 36is connected to the lower end of the bladder 20 to permit fluid 21 to bepumped from the bladder through the fluid conduit 18. The center section38 of the fluid conduit 18 lies along the inside inner wall of the pumpcasing 29 so that as the rotor 31 rotates its rotor tips 39 pinch thecenter section of the tube against the adjacent inner wall of the pumpcasing to cause the fluid 21 to be pushed or pumped through the conduit18. The outer end of the outlet section 37 is connected to a distensibleC-shaped member 40 that forms part of the distensible means 13. TheC-shaped member 40 has an inner layer 41 that is impervious to the fluid21. and an outer layer 42 that is compatible with body tissue. Locatedaround the outer periphery of the C-shaped distensible member 40 is arigid hoop 43 that prevents the distensible C-shaped member fromexpanding in an outward direction. The hoop 43 has a hole 44 thatreceives the outer end of the outlet section 37 and permits the outerend to be connected to the C- shaped member 40. As illustrated in FIG.3, the fluid conduit 18 also has an inner layer 45 that is impervious tothe fluid 21 and an outer layer 46 that is compatible with the tissuesof the body.

As best illustrated in FIG. 4, the ends of the C-shaped distensiblemember 40 have walls 47 and 48 that close the ends of the C-shapeddistensible member and seal the fluid 21 within the distensible member.The hoop 43 comprises two semi-circular sections 49 and 50. The section49 has mounting brackets 51 and 52 located near its ends and the sectionhas mounting brackets 53 and 54 that are adapted to be fastened to therespective mounting brackets 51 and 52 of the semi-circular section 49by respective pins 55 and 56 that pin the mounting brackets together.The two sections 49 and 50 that are separable and the shape of theC-shaped member 40 permit the surgeon to readily locate the distensiblemember around the pasage 14 without having to cut the passage as will bedescribed hereinafter in greater detail. The hoop 43 of the distensiblemeans 13 and the casing 29 of the pumping means 17 have respectivecircular cloth skirts 57 and 58 attached to their undersides that can bemade from a polyester or other body compatible material and that areadapted to be sewn to body tissue to anchor the pumping means 17 and thedistensible means 13 in place within the body 11. These cloth skirts 57and 58 will also permit body tissue to grow in between the fibers of thecloth with time and thus securely anchor the pumping means 17 and thedistensible means in place in the body 11. The cloth skirt 58 is splitin half as illustrated in FIG.

4 to permit separation of the two sections 49 and 50.

As best illustrated in FIG. 2 the pump activating means 19 comprises ahollow rectangular shaped casing 59 which houses a battery 60 and amotor 61 that is connected to the battery and operates from electricalpower supplied by the battery. A switch 62 is also provided that isadapted to electrically connect and disconnect the battery 59 from themotor 61. The motor 61 is operatively connected to a disc shaped magnet63 that is rotatably mounted within the casing 59 on a shaft 64 that hasits lower end secured to the inside lower inner wall of the casing. Themagnet 63 is adapted to be magnetically coupled to the pump magnet 32when the pump activating means 19 is brought into the vicinity of thepumping means 17 and the magnet 63 is located adjacent to the pumpmagnet as illustrated in FIG. 2. Upon activation of the pump activatingmeans 19 in this position, the rotating magnet 63 is adapted to causerotation of the magnet 32 and the connected pump rotor 31 so that thetips 39 of the rotor pinch the center conduit section 38 to pump fluidfrom the reservoir 12 through the conduit and into the distensiblemember 40 to cause it to distend and thus close the passage 14. The pumpactivating means 19 can also be reversed to cause the magnet 63 torotate in the opposite direction by pushing the switch in the otherdirection to reverse the electrical polarity of the power supplied bythe battery 59 to the motor 61. When this is accomplished, the rotatingmagnet 63 will then cause the pump magnet 32 and the connected rotor 31to rotate in the opposite direction to pump fluid from the distensiblemember 40 through the conduit 18 to the fluid reservoir 12 to cause thedistensible member to deflate and return to its normal shape so that thepassage 14 is permitted to open.

Another embodiment of the invention is illustrated in FIGS. 5 through 7that includes an implantable portion of the apparatus of the presentinvention for reversibly closing a natural or an implantable artificialbody passage, generally designated by the number 65, which isillustrated as being adapted to be implanted within the body 11. Theimplantable portion of the apparatus 65 includes the implantablereservoir 12, the implantable pumping means 17 and the implantable fluidconduit 18 that is connected to the reservoir and passes through thepumping means. However, the outlet section 37 of the conduit 18 isconnected at its outer end to a different form of implantabledistensible means generally designated by the number 66 which is adaptedto be operatively connected to the natural or artificial body passagesuch as the implanted or natural urethra 14 that is in turn connected tothe bladder which is connected to the kidneys 16. The pump activatingmeans 19 foractivating the pumping means 17 is also illustrated inFIG. 5located outside the body 11 in position to activate the pumping means inthe same manner as previously described in relation to the embodimentillustrated in FIGS. 1 through 4.

As best illustrated in FIGS. 6 and 7, the distensible means 66 comprisesa hollow annular or O-shaped distensible member 67. The O-shapeddistensible member 67 has an outer layer 68 that is compatible with bodyfluids and tissue and an inner layer 69 that is impervious to the fluid21. The distensible member 67 is adapted to be located withinthe bladder15 at the entrance to the urethra l4 and the inlet section 37 is adaptedto be inserted through a surgical opening 70 in the bladder 15. A clothskirt 7] is connected to the distensible member 67 and the cloth skirtis adapted to have its outer edge sewn to the interior of the bladder15. Connected to the lower surface of the distensible member 67 is aplastic funnel shaped positioning member 72 that has a central channel73 that extends completely through the funnel shaped member. The funnelshaped member 72 is adapted to fit within the inlet to the urethra 14and this funnel shaped member assists in keeping the distensible member67 in position.

An additional embodiment of the present invention is illustrated in FIG.8. As illustrated in FIG. 8, the distensible means 13 is adapted to beoperatively connected to the alimentary canal 74 in the body forreversibly closing the canal in a manner similar to that previouslydescribed in relation to the urethra l4 and the embodiment illustratedin FIGS. 1 through 4.

In order to practice the method of the present invention using theapparatus illustrated in FIGS. 1 through 4, the surgeon implants theimplantable fluid reservoir 12 in the abdominal region of the body 11and sews the tabs 24 through the use of the holes 25 in the tabs to bodytissue within the body so that the implantable reservoir is securedwithin the body. The fluid reservoir 12 is implanted close to the skinso that the self sealing membrane 26 faces outward toward the skin ofthe body and is located close to the skin. At the time of implantationof the fluid reservoir 12, it can contain the fluid 21 or it can beadded after implantation in the manner that will hereinafter bedescribed. At the time the implantable reservoir 12 is implanted, theimplantable fluid conduit 18 and the implantable .pumping means 17 arealso implanted in the body 11. The surgeon implants the pumping means 17close to the skin of the body 11 with the magnet 32 facing outwardtoward the skin of the body. When implanting the pumping means 17, thesurgeon sews the cloth skirt 58 to body tissue within the body so thatbody tissue will grow between the fibers of the cloth in order that thepumping means will be securely fastened within the body. At the sametime the pumping means 17, is implanted in the body the distensiblemeans 13 is also implanted. In implanting the distensible means 13, thesurgeon first removes the pins 55 and 56 and separates the twosemi-circular sections 49 and 50 and then passes the ends of theC-shaped distensible member around the body passage or urethra 14. Thepins 55 and 56 are then reinserted to secure the two semi-circularsections 49 and 50 together so that they encircle the body channel orpassage 14. The cloth 57 is then sewed to the body tissue so that bodytissue will grow between the fibers of the cloth and securely fasten thedistensible means 13 in position within the body 11. After the fluidreservoir 12, the pumping means 17, the fluid conduit 18 and thedistensible means 40 have been implanted within the body 11, the patientis given the pump activating means 19 so that he can activate theimplanted pumping means in the manner previously described.

If the implantable fluid reservoir 12 was implanted without having thefluid 21 in it, fluid must be added to the reservoir after it has beenimplanted. In order to add fluid to the implanted reservoir 12, thesurgeon locates the self sealing membrane 26 by locating the surroundingring 27 by feeling the ring through the skin. A hypodermic needle (notshown) is then inserted through the self sealing membrane 26 and therequired quantity of fluid 21 is injected into the reservoir 12. Itshould be noted that penetration of the back surface of the reservoir 12is prevented by the backing plate 28 that is connected to the inner backsurface of the reservoir. After the fluid 21 has been injected, thehypodermic needle is removed so that the self sealing membrane seals thefluid within the reservoir.

In order to practice the method of the present invention utilizing theapparatus illustrated in FIGS. through 7, the surgeon implants theimplantable fluid reservoir 12 and the implantable pumping means 17 inthe manner previously described in relation to the apparatus illustratedin FIGS. 1 through 4. The surgeon also implants the implantabledistensible means 66, however the distensible means is implanted insidethe bladder 15 near the inlet to the urethra 14 by surgically openingthe bladder so that the funnel shaped member 72 fits within the inlet ofthe urethra. At the time of implantation, the surgeon also sews thecloth skirt 71 that is attached to the distensible member 67 to theinner surface of the bladder 15. The fluid conduit 18 is also implantedin a manner similar to that previously described, however, the outer endof the outlet section 37 is passed through the surgical opening 70 inthe bladder wall. Fluid 21 can then be added to the reservoir 12 with ahypodermic syringe in the manner previously described if the reservoirwas implanted without containing any fluid. In addition, the patient isalso provided with external pump activating means 19 to activate theimplanted pumping means 17 in the manner previously described.

The method of the present invention associated with the structureillustrated in FIG. 8 is practiced in a manner similar to thatpreviously described with reference to the embodiment of the inventionillustrated in FIGS. 1 through 4, in that the implantable reservoir 12,the implantable pumping means 17 and the fluid conduit 18 are implantedin the body 11. However, instead of implanting the C-shaped distensiblemember 40 and connecting the two semicircular sections 49 and 50 aroundthe urethra 14 the C-shaped distensible memher and the two semi-circularsections 49 and 50 are implanted around the alimentary canal 74.

In order to utilize the embodiment of the invention illustrated in FIGS.1 through 4 the individual or the person tending to his needs places thepump activating means 19 against the body 11 so that the magnet 63 islocated in close proximity to the magnet 32 in the implanted pumpingmeans 17. The switch 62 is then pushed on to cause fluid to be pumpedfrom the reservoir 12 and this results in electrical energy beingprovided by the battery 60 to the motor 61 to cause the magnet 63 torotate in the proper direction. This rotation of the magnet 63, causesthe magnet 32 and the connected pump rotor 31 to rotate and as the rotorrotates its rotor tips 39 pinch the center tube section 38 against theadjacent inner wall of the pump casing 29 and this causes fluid 21 to bepumped from the implanted fluid reservoir 12 through the fluid conduit18 to the C-shaped distensible member 40 to cause the C- shapeddistensible member to expand or to become distended. It should be notedthat outward expansion of the C-shaped distensible member 40 isprevented by the hoop 43 so that the C-shaped distensible member expandsinward to close the natural or artificial body passage 14 and thusprevent urine from flowing from the bladder 15. If desired, the pumpactivating means 19 can then be slipped conveniently into a pocket inthe individuals clothing.

When the individual that has the apparatus 10 implanted in him wishes toempty his bladder 15 when it is becoming filled with urine, he or theindividual tending to his needs places the pump activating means 19against the surface of the body 11 so that the magnet 63 is located inclose proximity to the magnet 32 in the implanted pumping means 17. Theswitch 62 is then pushed on to the reverse position and this results inelectrical energy being provided by the battery 60 to the motor 61 tocause the magnet 63 to rotate in a direction that is reverse from thatpreviously described. This rotation of the magnet 63 causes rotation ofthe magnet 32 and the connected rotor 31 in a reverse direction to causethe rotor tips 39 to pinch the center tube section 38 against the innerpump casing wall and this causes fluid 21 to be pumped from theimplanted C-shaped distensible member 40 to the implanted fluidreservoir 12 so that C-shaped distensible member contracts or deflatesas illustrated in FIG. 4 and permits the body canal 14 to open so thaturine may pass through the canal from the bladder 15. After the-bladderis empty, the pumping means is activated in the reverse direction toclose the body canal 14 in the manner previously described.

The operation of the embodiment illustrated in FIGS. 5 through 7 issubstantially identical to that of the embodiment illustrated in FIGS. 1through 4, however when fluid is pumped into the O-shaped distensiblemember 67 it expands both in an outward and inward direction since thereis no hoop 43 surrounding the O- shaped distensible member. Expansion ofthe O-shaped distensible member causes the member to come in contactwith the bladder wall and also results in the closing of the opening inthe center of the O-shaped distensible member and as a result the lowerend of the bladder 15 and the inlet to the body canal 14 are blocked sothat urine cannot flow from the bladder. Operation of the pumping means17 in the reverse direction will cause the O-shaped distensible memberto contract so that an opening exists in the center of the O-shapedmember as illustrated in FIG. 4 and as a result urine can flow throughthe opening from the bladder 15.

The operation of the embodiment illustrated in FIG. 8 is similar to thatof the embodiment illustrated in FIGS. 1 through 4, however theindividual activates the pumping means 17 to open the distensible means13 when he senses that his alimentary canal 74 is full of fecal matter.After the alimentary canal has been evacuated the distensible means 13is filled with fluid so that the alimentary canal 74 is closed.

It will be appreciated that fluid 21 can be added or withdrawn from thereservoir 12 by use of a hypodermic needle and the self sealing membrane26 should this be necessary do to the presence of too much fluid withinthe reservoir or the lack of a sufflcient amount of fluid in thereservoir.

The outer layers of the apparatus of the invention that must becompatible with body tissues and fluids can be made from medical gradesilicone rubber such as that which is sold under the trademark Silasticby the Dow Corning Company of Midland, Michigan. The inner layers of theapparatus of the invention that must be impervious to and compatiblewith the fluid 21 can be made from polyvinyl chloride or some similarmaterial. The fluid 21 is preferably an aqueous NaCl solution that iscompatible with the body.

Although the invention has been described with reference to certainpreferred embodiments, it should be understood that many variations andmodifications may be made without departing from the spirit and scope ofthe invention as defined in the appended claims.

What is claimed is:

1. An implantable apparatus for reversibly closing a natural orimplanted urethra comprising an implantable fluid reservoir, animplantable O-shaped distensible member, a funnel shaped member forassisting in keeping said distensible member in place when implantedconnected to said distensible member, said funnel shaped member having achannel extending therethrough and being shaped to fit within the inletto a urethra in a body, and implantable pumping means operativelyconnected to said fluid reservoir and said distensible member forpumping fluid from said reservoir to said distensible member to causedistension thereof to close said urethra and to pump fluid from saiddistensible member to cause deflation thereof to open said urethra.

2. A method for reversibly closing a natural or implanted body passagecomprising the steps of: implanting, in the body, an implantablefluidreservoir, implantable pumping means operatively connected to saidimplantable fluid reservoir, an implantable C- shaped distensible memberoperatively connected to said pumping means, a hoop member having twoseparable sections located around said distensible member, and means forfastening the ends of said two separable sections together and duringsuch implantation separating the two separable sections of said hoopmember, passing the ends of said C-shaped distensible member around saidbody passage, and connecting the ends of said two, separable sections ofsaid hoop member by said fastening means; activating said pumping meansto pump fluid from said implantable fluid reservoir to said C-shapeddistensible member to cause distension thereof to reversibly close saidbody passage when it is desired to close said body passage; andactivating said pumping means to pump fluid from said distensible memberto said implantable fluid reservoir to cause deflation of saiddistensible member to open said body passage when it is desired to opensaid body passage.

3. The method of claim 2 wherein said implanting step further comprisesimplanting a cloth skirt attached to said hoop member and during suchimplantation connecting said cloth skirt to body tissue.

4. A method for reversibly closing a natural or implanted body passagecomprising the steps of: implanting, in the body, an implantable fluidreservoir, implantable pumping means operatively connected to saidimplantable fluid reservoir, and an implantable distensible memberoperatively connected to said pumping means and during suchimplantation, implanting said distensible member inside said bodypassage by surgically opening said body passage; activating said pumpingmeans to pump fluid from said implantable fluid reservoir to saiddistensible member to cause distension thereof to reversibly close saidbody passage when it is desired to close said body passage; andactivating said pumping means to pump fluid from said distensible memberto said implantable fluid reservoir to cause deflation of saiddistensible member to open said body passage when it is desired to opensaid body pas sage.

5. The method of claim 4 wherein implanting said implantable distensiblemember in said implantation step comprises implanting an O'shapedmember.

6. The method of claim 5 wherein said implanting step further comprisesimplanting means connected to said O-shaped distensible member forassisting in maintaining said distensible member in position inside saidbody passage and during such implantation, implanting said positionmaintenance assisting means inside said body passage by surgicallyopening said body passage.

7. The method of claim 6 wherein implanting said position maintenanceassisting means in said implantation step comprises implanting apositioning member having a channel extending therethrough.

b. The method of claim 7 wherein implanting position maintenanceassisting means in said implantation step further comprises implanting acloth skirt and further comprising sewing said cloth skirt to the innersurface of said body passage during such implantation.

9. A method for reversibly closing a natural or implanted urethracomprising the steps of: implanting, in the body, an implantable fluidreservoir, implantable pumping means operatively connected to saidimplantable fluid reservoir, an implantable distensible memberoperatively connected to said pumping means, and a funnel shaped memberhaving a channel extending therethrough connected to said distensiblemember and during such implantation placing said distensible member inthe bladder near the inlet to said urethra and fitting said funnelshaped member within the inlet to said urethra; activating said pumpingmeans to pump fluid from said implantable fluid reservoir to saiddistensible member to cause distension thereof to reversibly close saidurethra when it is desired to close said urethra; and activating saidpumping means to pump fluid from said distensible member to saidimplantable fluid reservoir to cause deflation of said distensiblemember to open said urethra when it is desired to open said urethra.

a w: m a lo-

1. An implantable apparatus for reversibly closing a natural orimplanted urethra comprising an implantable fluid reservoir, animplantable O-shaped distensible member, a funnel shaped member forassisting in keeping said distensible member in place when implantedconnected to said distensible member, said funnel shaped member having achannel extending therethrough and being shaped to fit within the inletto a urethra in a body, and implantable pumping means operativelyconnected to said fluid reservoir and said distensible member forpumping fluid from said reservoir to said distensible member to causedistension thereof to close said urethra and to pump fluid from saiddistensible member to cause deflation thereof to open said urethra.
 2. Amethod for reversibly closing a natural or implanted body passagecomprising the steps of: implanting, in the body, an implantable fluidreservoir, implantable pumping means operatively connected to saidimplantable fluid reservoir, an implantable C-shaped distensible memberoperatively connected to said pumping means, a hoop member having twoseparable sections located around said distensible member, and means forfastening the ends of said two separable sections together and duringsuch implantation separating the two separable sections of said hoopmember, passing the ends of said C-shaped distensible member around saidbody passage, and connecting the ends of said two separable sections ofsaid hoop member by said fastening means; activating said pumping meansto pump fluid from said implantable fluid reservoir to said C-shapeddistensible member to cause distension thereof to reversibly close saidbody passage when it is desired to close said body passage; andactivating said pumping means to pump fluid from said distensible memberto said implantable fluid reservoir to cause deflation of saiddistensible member to open said body passage when it is desired to opensaid body passage.
 3. The method of claim 2 wherein said implanting stepfurther comprises implanting a cloth skirt attached to said hoop memberand during such implantation connecting said cloth skirt to body tissue.4. A method for reversibly closing a natural or implanted body passagecomprising the steps of: implanting, in the body, an implantable fluidreservoir, implantable pumping means operatively connected to saidimplantable fluid reservoir, and an implantable distensible memberoperatively connected to said pumping means and during suchimplantation, implanting said distensible member inside said bodypassage by surgically opening said body passage; activating said pumpingmeans to pump fluid from said implantable fluid reservoir to saiddistensible member to cause distension thereof to reversibly close saidbody passage when it is desired to close said body passage; andactivating said pumping means to pump fluid from saId distensible memberto said implantable fluid reservoir to cause deflation of saiddistensible member to open said body passage when it is desired to opensaid body passage.
 5. The method of claim 4 wherein implanting saidimplantable distensible member in said implantation step comprisesimplanting an O-shaped member.
 6. The method of claim 5 wherein saidimplanting step further comprises implanting means connected to saidO-shaped distensible member for assisting in maintaining saiddistensible member in position inside said body passage and during suchimplantation, implanting said position maintenance assisting meansinside said body passage by surgically opening said body passage.
 7. Themethod of claim 6 wherein implanting said position maintenance assistingmeans in said implantation step comprises implanting a positioningmember having a channel extending therethrough.
 8. The method of claim 7wherein implanting position maintenance assisting means in saidimplantation step further comprises implanting a cloth skirt and furthercomprising sewing said cloth skirt to the inner surface of said bodypassage during such implantation.
 9. A method for reversibly closing anatural or implanted urethra comprising the steps of: implanting, in thebody, an implantable fluid reservoir, implantable pumping meansoperatively connected to said implantable fluid reservoir, animplantable distensible member operatively connected to said pumpingmeans, and a funnel shaped member having a channel extendingtherethrough connected to said distensible member and during suchimplantation placing said distensible member in the bladder near theinlet to said urethra and fitting said funnel shaped member within theinlet to said urethra; activating said pumping means to pump fluid fromsaid implantable fluid reservoir to said distensible member to causedistension thereof to reversibly close said urethra when it is desiredto close said urethra; and activating said pumping means to pump fluidfrom said distensible member to said implantable fluid reservoir tocause deflation of said distensible member to open said urethra when itis desired to open said urethra.